Associate Director, Epidemiology Analytics

Job Title : Associate Director, Epidemiology Analytics

Job Schedule : Hybrid is preferred - would consider a remote-based candidate - must be able to come in once a quarter.

RESPONSIBILITIES :

• Provide data management of diverse data (e.g., real-world setting and clinical trial) to set up epidemiologic data sets for various approaches, quantitative epidemiologic data analysis, interpretation of results, visualization of results, and generate manuscripts to disseminate findings.
• Conduct statistical analyses for epidemiological research and safety queries, including but not limited to :
• Descriptive summary and multivariable regression
• Exploratory analysis for safety endpoints in clinical trial data
• Setup and analysis of case-control and cohort study designs
• Signal detection analysis in spontaneous reports (e.g., FAERS, EVDAS)
• Signal detection / evaluation analysis in RWD
• Data mining (including free-text mining of unstructured data fields) using diverse data sources and methods
• Development of automation platform (e.g., R Shiny App) o Literature review and meta-analysis
• Collaborate with cross-functional teams to evaluate and manage adverse events and risks associated with pharmaceutical products.
• Participate in cross-functional meetings and provide input and guidance as needed.
• Participate in the preparation and submission of regulatory documents related to drug safety.
• Maintain and manage project plans to provide deliverables on time.
• Collaborate with global epidemiology teams to ensure consistency and quality in safety reporting and processes.
• Maintain compliance with all applicable regulations and guidelines related to pharmacovigilance and drug safety.
• Stay informed about emerging safety issues and contribute to the development of risk management strategies
• Mentor and provide guidance to junior team members.

Skills :

Education :

Master's degree (with 7+ years of experience) or PhD (with 4+ years of experience) in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology or related field